Table 1

Characteristics of regulatory data released by Canadian, European, USA and Japanese regulators*

Year of inception20192010 (Policy 0043), 2015 (Policy 0070)1998Unclear
Types of submissions disclosed†New submissions (after March 2019) and past submissions (any year not covered by new submissions)New submissions (Policy 0070; After January 2015 for market authorisation application or Article 58 procedure; July 2015 for line extension or new indication) and past submissions (Policy 0043; any year not covered by new submissions)New and past submissions, which can be requested through the Freedom of Information Act; 1938 to presentNew and past submissions
Scope of submissions disclosedApproved, unapproved or withdrawn productsApproved, unapproved or withdrawn productsApproved productsApproved products
Types of documentsOriginal documents submitted by manufacturersOriginal documents submitted by manufacturersSummaries and reviews written by FDA staff (Public access); original documents submitted by manufacturers (via Freedom of Information Act request only)Summaries and reviews written by PMDA staff; original documents submitted by manufacturers. Most were in Japanese with some reviews in English translation
How to accessHC Public Release of Clinical Information portalEMA clinical data sharing portalDrugs@FDA portal (summaries and reviews only); direct request (original documents submitted by manufacturers)Variety of webpages on PMDA website
URLshttps:// clinical-information.canada.cahttps:// clinicaldata.ema.europa.euhttps:// english/ search_index.html (English)
PmdaSearch/iyakuSearch/ (Japanese)
Who can accessPublicPublic (new submissions); requesters (past submissions; restricted to European Union members only)Public (summaries and reviews only); requesters (original documents submitted by manufacturers)Public
  • *Data sources: we consulted Egilman et al23 in addition to searching regulatory websites.

  • †New submissions refer to ones that enter the market prior to the inception of the databases, whereas old submissions refer to ones that are available before the launch of the databases.

  • EMA, European Medicines Agency; FDA, Food and Drug Administration; HC, Health Canada; PMDA, Pharmaceuticals and Medical Devices Agency.